Full labelling in English is required for all CPM. Chinese or other languages, if any, may be used in addition to English. The details required are as follows:
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Inner label must state:
内标签必须注明：
- Trade / brand name 药品商标
- Product name 药品名称
- Batch number 批号
- Expiry date 有效期
- Names and quantities of ingredients * 成份名称及份量*
(except for secret & protected formula) (除非是秘方或保护方)
* If inner label is too small, the information may be stated on the outer label.
* 如内标签的空间有限，这些资料必须注明于外标签。
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Outer label must state:
外标签必须注明：
- Trade / Brand name 药品商标
- Product name 药品名称
- Batch number 批号
- Expiry date 有效期
- Importer's or wholesaler's name and address ** 进口商／批发商的公司名称及地址**
- Manufacturer's name and address ** 制造商的公司名称及地址**
- Assembler's name and address (if any) ** 分装商的公司名称及地址(如有)**
- "Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority. Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。谨慎选用。"** (Please see below for more details) (请参阅下文了解更多详情)
** If there is no outer label, the information may be stated in the inner label.
** 若无外标签，这些资料必须注明于内标签。
Additional label 附加标签: "Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority. Consumer discretion is advised. 根据向当局提呈的资料允许作为中成药销售。谨慎选用。"
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Package insert must state:
说明书必须注明：
- Trade / Brand Name 药品商标
- Product Name 药品名称
- Manufacturer's name and address 制造商的公司名称及地址
- Names & quantities of ingredients 成份名称及份量
(except for secret & protected formula) (除非是秘方或保护方) - Dosage *** 药品用量***
- Indication *** 药品的适应症***
- Contraindication *** 药品的禁忌症***
- Side effects *** 药品的副作用***
- The frequency and method of administration *** 药品服食法***
*** If there is no leaflet, the information may be stated on either the inner or outer label.
*** 若无说明书，这些资料必须注明于内或外标签。
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Prohibition of Stipulation of Certain Diseases / Conditions 禁止涉及某些疾病／症状
The labels, packaging and package inserts of CPM shall not make references to any of the 19 diseases/conditions specified in the First Schedule to the Medicines Act:
中成药的标签，包装及说明书都不能提到以下的19种疾病／症状:
1. Blindness 失明 | 11. Leprosy 麻风 |
2. Cancer 癌症 | 12. Menstrual disorders 有关月经（月事）疾病 |
3. Cataract 白内障 | 13. Paralysis 瘫痪症 |
4. Drug addiction 毒瘾 | 14. Tuberculosis 结核病 |
5. Deafness 耳聋 | 15. Sexual function 性机能 |
6. Diabetes 糖尿病 | 16. Infertility 不育症 |
7. Epilepsy or fits 癫痫或抽搐 | 17. Impotency 阳萎 |
8. Hypertension 高血压 | 18. Frigidity 性冷感 |
9. Insanity 神经错乱 | 19. Conception and pregnancy 受孕或怀孕 |
10. Kidney diseases 肾病 |
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Secret & Protected Formula 秘方及保护方
The name of ingredients and their strengths need not be stated in the label and package insert if the formula of the CPM has been certified by the relevant health authority of the exporting country as "secret" or "protected".
如果该中成药被出口国卫生或管理当局证明为“秘方”或“保护方”,则不必在标签或说明书上透露药品的成分及份量。
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